MalfunctionGIT
DADE ACTIN FS ACTIVATED PTT REAGENT
Received Oct 17, 2005
Report 9610806-2005-00022 · MDR key 702453
Device
Generic name
Activated Partial Thromboplastin Time
Manufacturer
Dade Behring GmbhModel number
NACatalog number
B4218-100
Lot number
527263
Product problems
- High Test Results
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A CUSTOMER OBTAINED ERRONEOUSLY PROLONGED APTT RESULTS WITH A PT SAMPLE AND CONTROLS. PLASMA CONTROLS WERE OUT OF RANGE AND THE ERRONEOUS PT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PT; TREATMENT WAS NOT PRESCRIBED OR ALTERED BASED ON THE ERRONEOUS RESULTS. (NOTE: CUSTOMER UNABLE TO PROVIDE DATE OF EVENT).
Remedial action
- Recall